RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Revises Guidelines for Fast-Track Approval Pathways

The European Medicines Agency (EMA) has revised its guidelines on accelerated assessments and conditional marketing authorizations, a pair of processes that are central to its attempts to cut the time it takes for new medicines to reach patients.

EMA has made the tweaks in an attempt to improve fast-track procedures, in part by providing extra guidance on areas that have troubled drug developers and delayed progress in the past. In the case of the accelerated assessment pathway, this means the new version goes into more detail on what companies can do to show their product is relevant to a major public health interest.

Similarly, EMA has added details of how to demonstrate that a drug treats an unmet medical need to its advice on conditional marketing authorizations, while also clarifying how to substantiate a positive benefit-risk balance using limited data. The conditional authorization guidelines now also feature more information about what data companies should include in annual renewal submissions.

The latest version of the accelerated assessment guidelines may also provide a launchpad for a new policy under consideration at EMA. If the plan comes to fruition, EMA will use the guidelines’ criteria as the basis of a policy to help with development and accelerated assessment of innovative drugs of major interest in terms of public health, notably therapeutic breakthroughs that treat unmet needs.

EMA discusses the proposed scheme in a note on public consultation at the start of the accelerated assessment draft guidelines. Both sets of revised guidelines are open for comment until the end of September.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has posted a clutch of important authorization recommendations, including favorable rulings for GlaxoSmithKline’s malaria vaccine and Sanofi’s PCSK9 cholesterol drug.

The decisions on the malaria vaccine, Mosquirix, and cholesterol drug, Praluent, are notable events in terms of public health and the pharma industry. Having won CHMP’s support, Mosquirix is set to become the first malaria vaccine to come to market. The vaccine, which is recommended for use outside the EU, is far from perfect, but given the toll inflicted by malaria even a partly effective product could have significant health implications.

CHMP’s recommendation of Praluent, while perhaps less important from a global health perspective, is a big moment in the race to capture the much-discussed market for PCSK9 inhibitors. Sanofi has developed Praluent with Regeneron, but the partners are slightly behind Amgen in Europe, where their rival’s PCSK9 inhibitor Repatha is already approved. In total, CHMP recommended the approval of 10 drugs in its latest batch of decisions. CHMP also backed four label extensions.

UK Considers Mimicking Sunshine Act Amid Pay for Play Allegations

Senior politicians in the United Kingdom are considering proposing legislation to force healthcare professions to fully disclose payments from biopharma companies. Openness to introducing such a law, which would echo the United States’ Sunshine Act, has increased in the wake of recent events.

The Telegraph pushed the topic up the news agenda when it published an undercover investigation that appears to show National Health Service (NHS) workers negotiating deals with drug makers. In one case, a staffer quoted $23,000 to set up an advisory board meeting. Such allegations and others that say people working within the NHS accepted nearly $800 a day to attend a meeting in Germany have raised doubts about the process the organization uses to make drug coverage decisions.

Officials within the NHS and government have responded by raising the possibility of new laws. “These allegations raise the question of whether this country should now legislate for a so-called Sunshine Act, requiring full disclosure of any payments made by a pharmaceutical or device company to a health professional or NHS employee,” an NHS England representative said. Health Secretary Jeremy Hunt is considering the idea, although the industry favors self-regulation.

EMA Opens Door to use of QR Codes on Labeling and Packaging

EMA has published general principles for the use of QR codes on drug labeling and packaging. The document lays out what companies should consider before filing a request to use QR codes with EMA, as well as details of how to implement the technology if they receive regulatory clearance.

QR codes have been around since the 1990s, but started to gain popularity in the West in parallel to the rise of smartphones. When scanned with a smartphone, the square, barcode-like symbols take the user to a specific website, add a contact to their address book or perform another action. While the concept was pushed by marketers, the public has been slow to embrace the technology. Even so, EMA reports a growing number of applicants to the centralized procedure want to use QR codes.

The regulator has moved to help such companies by creating a five-page document detailing what information to include in applications. EMA wants details of the positioning of the QR code on the packaging, the platform hosting the content to which it links — in many cases this will be a website — and an overview of the information it contains. The content accessible via the QR code must also be available by typing a URL into a browser.

EMA Starts Pilot Program to Boost use of Scientific Advice in Post-Approval Studies

EMA has started a 12-month pilot program to encourage companies to seek scientific advice before starting post-authorization safety studies. The scheme is voluntary, but EMA hopes companies will see it as an opportunity to improve the designs of their trials.

At least two members of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will join the Scientific Advice Working Party (SAWP) for the duration of the pilot project. Companies can ask the experts specific questions about the design of their studies at any stage of the process, potentially increasing interaction between sponsors and the regulator while cutting the time it takes to review the protocol.

EMA has released an updated Q&A document to help companies through the process and a letter of intent sponsors can send to the regulator to request scientific advice.

Other News:

EMA has released final guidelines on the Summary of Product Characteristics (SmPC) for human fibrinogen. The document, which is due to come into force on 1 February 2016, gives applicants and regulators a shared set of guidelines to shape their decisions about what information to include in the documentation for drugs to treat or prevent bleeding in patients. Final Guidelines

The Icelandic Association of the Pharmaceutical Industry (Frumtök) has adopted the disclosure code of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Frumtök is not a member of EFPIA but decided to implement the code from earlier this year. Policy and Medicine

The date on which EMA will ban drugs tested by GVK Biosciences is edging closer, increasing talk in the Indian media about the effect the action will have on the industry. Business Standard, Times of India, More

An independent committee has told the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) that alteplase is safe and effective when used to current guidelines. Alteplase is a treatment for ischemic stroke. Press Release